Executive Technology Transfer - Vapi, India - Quality HR Services

Quality HR Services

Verified Company

Vapi, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Opening: 1 Nos

Job ID:

Employment Type:

Full Time- Reference:

Work Experience: 8.0 Year(s)

To 10.0 Year(s)- CTC Salary: 7.00 LPA TO 9.00 LPA- Industry: Pharma/Biotech/Clinical Research- Qualification: B.Pharma - Pharmacy; M.

Pharma - Pharmacy- Location:

Vapi

Posted On: 16th Feb, 2023

**Position: Executive Technology Transfer

Location:
Vapi

Experience: 8- 10 Years

Industries:
Pharma

Responsibilities:

To coordinate between R & D / client (product transferring unit) and all applicable stake holder departments in the plant (receiving unit) so as to ensure the smooth and effective transfer of product.
To evaluate / review the necessary documentation provided from transferring party (from R & D, Client etc.) with respect to product and process criteria in terms of facility, available equipment's etc.
Responsible for transfer of technology in planned approach with proper documentation (in concordant with the quality system) which shall covers all aspects of product development, manufacturing and quality control.
To review of product development summary report from transferring site in order to gain / understand the product as well as process knowledge and to ensure the smooth transfer of any new product to receiving site by organizing a proper and systematic meeting / discussion with involvement of all relevant stake holders from both transferring and receiving site.
Responsible to ensure the clarity, accurate information, adequate communication / feedback in order to improve the understanding and to maintain the transparency of new product which is to be transferred.
Responsible to prepare of batch documents like MFC, MPR, BMR, BPR, protocol, report and other technical documents (if any) with respect to R & D scale / pilot batch(s), scaleup batch(s), preexhibit / confirmatory batch(s), exhibit / submission
To monitor and provide assistance during execution of submission / exhibit batch(s) and initial commercial validation batch(s) of any new product as R & D representative based on the minimum criticality / lower risk criteria towards the process / product.
To provide necessary assistance regarding challenges faced during execution scaleup, preexhibit / confirmatory, submission / exhibit batch(s) and also initial commercial validation batch(s) i.e., PPQ batch(s) in terms of deviation / incident investigations and to frame necessary Corrective Action and Preventive Action (CAPA) towards way forward activities.
To participate in meetings, telecom etc. between inter/intradepartments and also with clients (if applicable) related to new product transfer, status update and filing / submission aspects.
Responsible to take care Sample registration work for different Regulatory/Non-Regulatory market.
Toensure that the appropriate process validations of a product and calibration/qualification of equipment are performed and recorded and the reports made available.

Required Skills: